NDC 75840-094 Previdolrx Analgesic Pak

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
75840-094
Proprietary Name:
Previdolrx Analgesic Pak
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
75840
Start Marketing Date: [9]
12-15-2015
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BROWN (C48332 - LIGHT BROWN)
PINK (C48328 - OPAQUE)
BROWN (C48332 - REDDISH BROWN)
Shape:
ROUND (C48348)
CAPSULE (C48336)
Size(s):
10 MM
18 MM
Imprint(s):
P;75
APO;020
Score:
1

Code Structure Chart

Product Details

What is NDC 75840-094?

The NDC code 75840-094 is assigned by the FDA to the product Previdolrx Analgesic Pak which is product labeled by Genpak Solutions, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 75840-094-01 1 kit in 1 kit * 30 capsule, delayed release in 1 bottle (60505-0065-0) * 60 g in 1 tube (0603-0648-88) * 60 tablet, delayed release in 1 bottle (16571-201-06). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Previdolrx Analgesic Pak?

Carefully consider the potential benefits and risks of Diclofenac Sodium Delayed-release Tablets and other treatment options before deciding to use Diclofenac Sodium Delayed-release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Diclofenac Sodium Delayed-release Tablets, are indicated:• For relief of the signs and symptoms of osteoarthritis• For relief of the signs and symptoms of rheumatoid arthritis• For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis Omeprazole is a proton pump inhibitor indicated for:• Treatment in adults of duodenal ulcer (1.1) and gastric ulcer (1.2)• Treatment in adults and children of gastroesophageal reflux disease (GERD) (1.3) and maintenance of healing of erosive esophagitis (1.4)• Pathologic Hypersecretory Conditions (1.5)The safety and effectiveness of omeprazole in pediatric patients <1 year of age have not been established. (8.4)

Which are Previdolrx Analgesic Pak UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Previdolrx Analgesic Pak Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Previdolrx Analgesic Pak?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".